25 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BENCOX Mirabo Z Cup Cortinium
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·03596010605047·MTO BULLET ACL ECCENTRIC 10MM
PosiSep X2 0.7" x 1.7"
FDA UDI
HEMOSTASIS, LLC·00858439001880·PosiSep X2 devices are patient-comfortable spon...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514507·"An absorbent paper points is an endodontic pap...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106140·Trial, 26 x 14mm, 8 Degree, Tapered, Straight
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FiteBac Antimicrobial Cavity Cleanser
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® C&S TRANSFER STRAW KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSM·May 31, 2018
NAVIO HANDPIECE
FDA Adverse Event
Malfunction
·BLUE BELT TECHNOLOGIES·Product code OLO·April 23, 2020
BD VACUTAINERR® PLUS PLASTIC URINE C&S PRESERVATIVE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSM·December 8, 2017
LOGIC TIBIA PS MOD INSRT SZ 2.5 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 29, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 23, 2008
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURER·Product code FWM·August 10, 2011
FORTIFY VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·November 17, 2021
L3C0600 - CURE PRODUCTS
FDA Adverse Event
Injury
·CONVATEC·Product code KOD·May 5, 2022
L3C0600 - CURE PRODUCTS
FDA Adverse Event
Injury
·CONVATEC·Product code KOD·May 5, 2022
Alinity m Integrated Reaction Units (IRU)
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·March 9, 2022
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021